Generic and Innovator Drugs provides a complete reference to significant developments in FDA approval requirements, including extensive coverage of innovator drugs, the drug approval process and patent term extension.The Fifth Edition includes expanded coverage of relevant issues, including: A chapter on FDA regulation of biologic drugsAn explanation of the interpretation by the FDA and the courts of the market exclusivity provisions FDA administersAn explanation of the new user fee legislation and FDA commitments in ...
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Generic and Innovator Drugs provides a complete reference to significant developments in FDA approval requirements, including extensive coverage of innovator drugs, the drug approval process and patent term extension.The Fifth Edition includes expanded coverage of relevant issues, including: A chapter on FDA regulation of biologic drugsAn explanation of the interpretation by the FDA and the courts of the market exclusivity provisions FDA administersAn explanation of the new user fee legislation and FDA commitments in response to that legislationA chapter reflecting new FDA requirements on drug exportsPlus, the full text of relevant statutes, regulations, FDA guidelines, memoranda, correspondence, and more.This one-volume guide contains exhaustive discussions and analyses of all the major regulatory and legal actions from the
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